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Migraine Headache research study

What is the primary objective of this study?

Migraine headache occurs frequently in women more than men and is associated with symptoms
not only of significant pain but also of symptoms typically including of photophobia,
phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition from
lack of concentration, difficulty in word finding or inability to remember. Many of these
cognitive symptoms seem to be independent of the pain intensity and may occur completely
separately from the headache pain but can be disabling. It is likely that the frequency and
importance of cognitive symptoms associated with migraine are underreported.
The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an
efficient and accurate measure of cognition during migraine headache. Treximet is a new
migraine treatment recently FDA approved for the treatment for the relief of acute migraine
that may be effective for the cognitive symptoms for migraine patients who have a history of
cognitive dysfunction during a migraine headache. The primary efficacy parameter is to
evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute
migraine headache measuring neuropsychological function using the MEWT during the migraine
and comparing that score with a prior MEWT score when the patient had no migraine symptoms. A
double blind, placebo-controlled, crossover study was chosen so that each patient may be her
or his own control.
It is the intent of this study to determine the type and intensity of cognitive dysfunction
associated with migraine headache and to what extent that Treximet may relieve the cognitive
dysfunction in a safe and effective manner.

Who is eligible to participate?

Inclusion Criteria:
1. Females and male subjects, ages 18-65 inclusive
2. Have migraines with or without aura as expressed by the International Headache Society
(IHS) criteria for at least six months and at least one attack per month for three
months prior to screening
3. If female, have an acceptable method of contraception during the study, have no plans
to become pregnant and have a negative urine pregnancy test at screening and
throughout the study.
4. Must be able to follow study protocol including all neuropsychological testing, MEWT
assessments and evaluation forms.
5. Must be willing and able to provide written informed consent
Exclusion Criteria:
1. Have more than 15 headache days per month
2. Have hemiplegic or secondary headaches
3. Have significant risk factors for cardiovascular or cerebrovascular disease as
assessed by the investigator
4. Are taking any medication that is contraindicated with a triptan or NSAIDs
5. Have any significant concomitant disease
6. Have any allergy to triptans, aspirin or NSAIDs
7. Have a history of substance abuse, psychiatric illness in the last 5 years
8. Are participating or have participated in an investigational drug trial within the
last 30 days

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Treximet, cognitive testing

2Placebo, Cognitive testing

Study Status

Unknown status

Start Date: February 2009

Completed Date: September 2009

Phase: N/A

Type: Interventional

Design:

Primary Outcome: To evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute migraine headache on the neuropsychological function before treatment and at one and two hours after treatment of a migraine.

Secondary Outcome: To assess incidence and types of neuropsychological deficits by MEWT in patients with acute migraine headache before treatment.

Discuss Migraine

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